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BD (Becton, Dickinson and Company) Process Scientist in Baltimore, Maryland

Job Description SummaryThe Process Scientist is responsible for working as part of an R&D team in the design transfer of reagent and consumable manufacture processes to an Operations team. With leadership from a R&D manager, this individual will play an integral role in designing and executing experiments to comprehend and optimize the formulations, manufacture and packaging of reagents and consumables associated with IVD molecular diagnostic devices. The successful individual will also assist in demonstrating the robust performance and stability of product using established quality policies and procedures and will be responsible for the documentation of summary reports; manufacturing, quality control and standard operating procedures; and verification/validation protocols and reports associated with development of successful products. The candidate will be expected to work with limited supervision and apply experiential knowledge to analyze, interpret and communicate work products to a range of technical and non-technical stakeholders. The ideal candidate will have strong experimental design/analysis, documentation and verification/validation skills and will be able to work across disciplines/functions to apply best practices toward design transfer of product to manufacture.

Job Description

Duties and Responsibilities:

  • Applies knowledge inscientific/engineeringtheories and innovative ideas to the execution of process development and design transfer to manufacture across multiple product development efforts to meet business objectives.

  • Collaborates with representatives from R&D, Operations, Quality and Engineering to develop and execute on process development and design transfer plans that are aligned with product requirements, specifications, manufacture capability, quality policies/procedures and best practices.

  • Applies effective and efficient experimental designs and analyses using appropriate tools and statistical robustness. Develops and/or adapts procedures to meet specific objectives and solve problems.

  • Interprets experimental results to determine appropriate course of action. Acts as a sounding board for testing scientific hypotheses and as a stimulus for the highest caliber of scientific rigor.

  • Formulates and conducts systematic investigation of problem areas of considerable complexity which may require application of a series of complex and conceptually related studies.

  • May assist in the development of policies/procedures to ensure effective achievement of scientific objectives.

  • Considers trade-offs between product features, product cost & manufacturability, project schedule, and resource availability when providing input to approach.

  • Drafts documents for Design Input, Design Verification, Design Validation, and Design Transfer. Also documents executive summary reports that outline approach, results and conclusions associated with aspects of design development and optimization.

  • Provides input into the establishment and implementation of SOPs for manufacturing processes and manufacturing equipment.

  • Interfaces with other departments and internal/external partners to facilitate product development.

  • May be responsible for the maintenance of complex laboratory equipment and facilities.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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  • Knowledge of, and experience in, process development associated with medical devices. Demonstrated ability to apply innovative approaches to diagnostic product development.

  • Knowledge of current state-of-the-art in nucleic acid extraction and amplification technologies as well as design and development of qualitative and quantitative real time PCR in-vitro diagnostic assays.

  • Demonstrated ability to learn new scientific and technological approaches.

  • Mastery of scientific method, experimental design, data analysis, and results interpretation.

  • Understanding of the theory of measurement, sources of error, and comparative advantages of different methodologies.

  • Demonstrated ability to work effectively within teams, across functions and with technical and business leaders.

  • Strong verbal, written, and interpersonal communication skills.

  • Capable of balancing multiple priorities and working under deadline pressure.

  • Working knowledge of the pertinent Quality Systems/Regulations (i.e. Quality System Regulation, ISO, FDA).

Education and Experience:

  • B.S in scientific discipline (molecular biology, bioengineering, biochemistry, microbiology or virology) or equivalent plus a minimum of 3 years’ experience in research and development environment specializing in developing In Vitro Diagnostic products in a regulatory environment.

  • Demonstrated ability to learn new scientific and technological approaches.

  • Application of complex experimental (e.g. DOE) and statistical methods to product optimization and problem solving is essential.

  • Experience in a regulated industry required, FDA preferred.

  • Knowledge and experience in reagent and consumables development and manufacture (e.g. plastics design and manufacture, reagent formulation and packaging) is preferred.

  • Knowledge of current state-of-the-art in nucleic acid extraction and amplification technologies as well as design and development of qualitative and quantitative real time PCR in-vitro diagnostic assays is preferred.

Primary Work LocationUSA MD - Sparks - 52/54 Loveton Circle

Additional Locations

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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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